Intraluminal support structure and prosthetic valve for the same

ABSTRACT

An intraluminal support structure having a delivery configuration that is a crimped open configuration to increase flexibility while maneuvering in the anatomy and having a small scarring signature.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/627,316 (Attorney Docket No. 62218-703.831), filed Dec. 29, 2019,which is a national stage application of PCT Application No.PCT/IL2018/050698, (Attorney Docket No. 62218-703.601), filed Jun. 26,2018, which claims the benefit of U.S. Provisional No. 62/526,693(Attorney Docket No. 62218-703.101), filed Jun. 29, 2017, the entirecontent of each of which are incorporated herein in their entirety.

FIELD OF THE INVENTION

The present invention relates to an intraluminal support structuredevice, system and a method for delivery of the same in a trans-cathetermethod, and in particular, to such an intraluminal support structurethat is delivered in a crimped open configuration and is transitioned toa final folded and closed configuration during deployment within theanatomy.

BACKGROUND OF THE INVENTION

Across the globe Heart Valve Disease (HVD) affects many people globally.HVD manifests in abnormal valve leaflet tissue in various ways includingexcess tissue growth, tissue degradation, tissue rupture, tissuehardening, tissue calcification, abnormal tissue re-positioning inresponse to cardiac configuration during different stages of the cardiaccycle, for example annular dilation or ventricular reshaping. Suchtissue deformation leads degrading valve function for example leakage,backflow as a result of valve insufficiency, resistance to blood forwardflow as a result of valve stenosis.

In such situations the best treatment mode is generally placement of atrans-catheter valve prosthesis. A prosthetic valve generally provides afunctional replacement of a damaged heart valve. In recent years thepreferred mode of delivery of placement of a prosthetic valve has beenvia catheterization techniques.

U.S. Pat. No. 4,733,665 to Palmaz discloses a wire mesh tube vasculargraft (stent) that is expanded within a blood vessel by an angioplastyballoon associated with a catheter for repairing blood vessels narrowedor occluded by disease.

U.S. Pat. No. 5,836,964 to Richter et al, discloses a method forfabricating as cylindrical stent from sheet metal from the manufactureprocess and up to before delivery in patient.

U.S. Pat. No. 5,441,515 to Khosravi et al, discloses an intravascularstent comprising a cylindrical sheet having overlapping edges thatinterlock. The edges have a series of protrusions and apertures thatinterlock and ratchet as the stent expands to an open position tosupport a section of arterial wall. The interlocking mechanism used toensure the stent's patency while imparting some flexibility to thestent.

U.S. Pat. No. 5,411,552 to Anderesen et al, disclose a method forimplantation of a valve prosthesis via balloon catheterizationtechniques making it possible to insert a cardiac valve prosthesiswithout an invasive surgical procedure including opening the thoraciccavity.

U.S. Pat. No. 6,540,777 to Stenzel describes a locking stent having atleast one lockable cell which includes a first locking member and asecond locking member that are interlocked to impart increasedscaffolding strength to the stent.

A stent is typically delivered in an unexpanded state to a desiredlocation in a bodily lumen and then expanded. The stent may be expandedvia the use of mechanical device such as a balloon or the stent may beself-expanding.

SUMMARY OF THE INVENTION

Trans-catheter therapies for structural heart diseases raised the needfor the delivery of large devices through native vessels, cardiac wallsand the cardiac septum. However, radial crimping of these devices, asprovided by the state of the art devices, creates a rigid and relativelylarge stem inside the device's delivery sheath. These limitations, bothin rigidity and size, result in the limited movement and maneuverabilityduring the procedure. In particular it is difficult to maneuver thedevice in acute angles during the procedure.

Furthermore, the large size (diameter) of the state of the art devicefurther leave large orifices in the cardiac septum at the end of theprocedure.

In the actual state of art, all the devices are crimped and deployed ina radial manner, which means that currently there isn't any availableoption to deliver such devices without significant septum damage andfurther lead to significant maneuverability limitation.

There is an unmet need for, and it would be highly useful to have, astent that is more flexible in its crimped state so as to facilitatedelivery in any anatomy and to allow for easier maneuverability throughthe tortuous anatomy. Accordingly, increased stent flexibility greatlyincreases the capability of delivery and deployment of stents.

While flexibility is important stents must also exhibit high scaffoldingin the expanded and/or non-crimped state so as to increase the stabilityof the stent within the delivery site.

This dual need for flexibility in the crimped state and high scaffoldingin the expanded (non-crimped) state presents an unsolved problem in theart as the two characteristics are inversely proportional. Specifically,as stent flexibility is increased, scaffolding is decreased andsimilarly, as scaffolding is increased, flexibility is decreased.Accordingly, there remains a need for a stent having a high degree offlexibility in the crimped low profile state and high scaffolding in theexpanded final state.

The prior art discloses cylindrical stents that are convenient forcatheterization delivery in that they can assume a small diameter andcan be readily expanded with a balloon or alternatively may beconfigured to be self-expanding. However, due to the cylindricalconfiguration of stents there is an inherent structural limitation inthe level of available flexibility, especially of larger stentsconfigured to form valve prosthesis.

Trans-catheter delivery solution for the treatment of valvular diseasewherein, valve replacement is provided by way of catheter facilitateddelivery, has further raised the need to deliver a relatively largestents integrated with its biological component, forming a prostheticvalve. Prosthetic valves are introduced to the cardiac anatomy throughnative vessels, cardiac walls and septum. Accordingly, large stentsforming a valve prosthesis, for the purpose of valve delivery, require ahigh degree of flexibility to facilitate the catheter delivery process.

To this end, state of the art stents are difficult to maneuver withinthe delivery catheter because of their length and relatively largediameter makes them difficult to maneuver in the tortuous anatomy.Furthermore, the large stent diameter, when in crimped or low profileconfigures, makes it difficult for the required maneuverability.Specifically establishing acute angels during the delivery is currentlynot possible with state of the art prosthetic valves, due to thediameter of the cylindrical stent. Furthermore, during trans-catheterdelivery the prosthetic valve stent is introduced through the cardiacseptum. Current large diameter stent disadvantageously leave a largeorifice in the cardiac septum.

Accordingly it would be advantageous to have a stent capable ofincreased flexibility while maintaining minimal dimensions in thecrimped/small configuration.

Embodiments of the present invention provide a stent having a planarconfiguration utilized during the delivery phase wherein the supportstructures assumes a low profile crimped open configuration. The planarstent is configured to assume a final closed folded configuration duringdeployment at the tissue targeted site.

In embodiments the planar stent may be fit with a valve prosthesis toform a valve prosthesis that may be delivered by transcatheterization.

In one embodiment, the invention is directed to stents comprising aplurality of interconnected cells where at least one of theinterconnected cells is a lockable cell. The lockable cell includes afirst locking member and a second locking member disposed opposite thefirst member. The first and second locking members are movable between afirst position in which they do not lock with one another to a positionin which they lock with one another.

Within the context of this application the term “open crimpedconfiguration” substantially refers to a crimped small profileconfiguration of the support structure in its delivery state that is tobe delivered to an implantation site with a delivery tool such as acatheter. The term “open” refers to a non-tubular or non-cylindricalstructure, for example such as a stent or valve. Therein the term “opencrimped configuration” refers to a non-radially crimped supportstructure.

Within the context of this application the term “open non-crimped planarconfiguration” substantially refers to a configuration of the supportstructure in its flat planar and preferably single layer configurationhaving maximal dimension prior to being crimped. The term “open” refersto a non-tubular or non-cylindrical structure, for example such as astent or valve.

Within the context of this application the term “open” in reference to aconfiguration of the support structure refers to a non-tubular ornon-cylindrical structure, for example such as a stent or valve. Theterm “open” may be utilized to interchangeably refer to a single layerplanar structure that is substantially flat or to a multilayered planarstructure that is substantially flat.

Within the context of this application the term closed non-planar foldedconfiguration refers to the final support structure configuration aswould be placed within the anatomy, for example in the form of a tubularstent and/or cylindrical valve. The closed configuration thereforerefers to the final shape and/or state of the vessel support structurefollowing its transformation.

In embodiments of the present invention provides an intraluminal supportstructure, for example a stent and/or prosthetic valve, having a bodycapable of transitioning between three configuration including, an opennon-crimped planar configuration having a long axis and a short axis, anopen crimped configuration and a closed non-planar folded configuration;

The support structure characterized in that the open non-crimped planarconfiguration is crimped along the long axis to transition the body toform the open crimped configuration and providing the body with aminimal short axis and a maximal long axis therein providing the opencrimped configuration with increased flexibility.

In embodiments the open crimped configuration is associated with adelivery carrier member in the form of a catheter or sheath defining adelivery system; the delivery system is utilized for introducing thesupport structure to a body for implantation at a delivery site orimplantation site; and wherein the open crimped configuration iscontrollably disassociated from the delivery system to be deployed atthe delivery site, and wherein during deployment the open crimpedconfiguration transitions to assume the closed non-planar foldedconfiguration, wherein the transition is established by way of at leastone of expansion, torsion or folding and wherein the closed non-planarfolded configuration is finalized by closing the body by interlocking anend thereof along one of the long axis or the short axis.

In embodiments the closed non-planar folded configuration may be closedby overlapping and interlocking portions of the body along one of thelong axis or the short axis.

In embodiments the support structure body may be provided from anarrangement of a plurality of filaments forming a planar scaffold, andwherein the filaments form a interlinking points defining aninterlinking angle at the interlinking point that define a planaropening formed from at least two opposing interlinking points,characterized in that the support structure is configured to transitionbetween the open non-crimped planar configuration to the crimpedconfiguration by adjusting the interlinking angle.

In embodiments the support structure body may further comprises at leastone axial support member along at least a portion of the length of thebody along the long axis. In embodiments the axial support member isdisposed between two opposing long edges of the long axis. Inembodiments the support structure may comprise at least two axialsupport members forming an upper portion, medial portion, and lowerportion along the support structure body.

In embodiments the axial support member is provided form of a continuousflexible sheet.

In embodiments the length of the short axis may be reduced by at least20% and up to about 80% when transitioning between the open non-crimpedplanar configuration and the crimped configuration.

In embodiments the length of the long axis increases by a factor of upto about 100% when transitioning between the open non-crimped planarconfiguration and the open crimped configuration.

In embodiments the support structure may further comprises a valve bodydefining a prosthetic valve. In embodiment the valve body is configuredto form a prosthetic valve in the form for example including but notlimited to: semilunar valve, pulmonary valve, aortic valve,atrioventricular valve (AV valve), mitral valve, bicuspid valve,tricuspid valve, sphincter, cervix, the like or any combination thereof.

In embodiments the valve body may be provided from optional materialsfor example including but not limited to biological tissue, biologicalmatter, engineered materials, grown materials, transplanted tissue,biocompatible polymeric materials, the like and any combination thereof.

In embodiments the support structure may be coated with at least one ormore selected from the group consisting of an agent, a medicament, adrug, an eluting medicament, a controlled release medicament, acontrolled release agent, any combination thereof.

In embodiments the present invention provides a method for delivering anintraluminal support structure having a body capable of transitioningbetween three configuration including, an open non-crimped planarconfiguration having a long axis and a short axis, an open crimpedconfiguration and a closed non-planar folded configuration; the supportstructure characterized in that the open non-crimped planarconfiguration is crimped along the long axis to transition the body toform the open crimped configuration and providing the body with aminimal short axis and a maximal long axis therein providing the opencrimped configuration with increased flexibility, the method comprising:

mounting the support structure in the crimped configuration on a distalend of a delivery catheter for intraluminal delivery through a bodylumen therein defining a loaded catheter ready for introduction into thebody;

introducing the catheter into the body and advancing the loaded catheterthrough the body lumen and anatomical tissue until reaching the deliverysite (implantation site);

deploying the support structure in the delivery site by extracting thecrimped support structure from the catheter and allowing the crimpedplanar support structure to transition by way of expanding and foldingas it is extracted from catheter so as to assume a non-planar foldedconfiguration and closing the non-planar folded configuration byinterlocking corresponding locking members so as to assume the finalclosed non-planar folded configuration; maneuvering the closednon-planar folded support structure to its final implanted location; andwithdrawing the catheter from the body lumen.

In some embodiments the method may further comprise the stage ofradially expanding the non-planar folded support structure to assume itsimplanted diameter. Optionally radial expanding is provided in a gradualmanner including at least two individual radial expanding processes.

In some embodiments the method may further comprise suturing at least aportion of the closed non-planar folded support structure configurationonto a valve annulus.

In embodiments transitioning may be provided by way of exposing thesupport structure to a transitioning triggering agent or signal.Optionally the triggering agent may be selected from at least one ormore from the group consisting of: exposure to a temperature change,exposure to a temperature increase, exposure to a temperature decrease,exposure to a chemical agent, exposure to an electromagnetic field,exposure to an electromagnetic current, exposure to an acoustic signal,exposure to an optical signal, exposure to an magnetic field, and anycombination thereof.

In some embodiments the method may further comprise delivering at leasttwo or more crimped planar support structures to the delivery site andcoupling the two or more support structures within the delivery site toform a complex non-planar folded support structure configuration made oftwo or more crimped planar support structures.

In embodiments of the present invention comprises a delivery system fordelivering and deploying the support structure according to embodimentsof the present invention, as described above, wherein the deliverysystem comprises a catheter or sheath capable of receiving the supportstructure in the crimped configuration and wherein the foldedconfiguration may be of any diameter or size.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. The materials, methods, andexamples provided herein are illustrative only and not intended to belimiting.

Implementation of the method and system of the present inventioninvolves performing or completing certain selected tasks or stepsmanually, automatically, or a combination thereof.

While the present description and figures depict a three leaflet valve,however embodiments of the present invention are not limited to such avalve configuration and may be accordingly be configured to form anyvalve type with any number of leaflets.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin order to provide what is believed to be the most useful and readilyunderstood description of the principles and conceptual aspects of theinvention. In this regard, no attempt is made to show structural detailsof the invention in more detail than is necessary for a fundamentalunderstanding of the invention, the description taken with the drawingsmaking apparent to those skilled in the art how the several forms of theinvention may be embodied in practice.

In the drawings:

FIG. 1A-1D show schematic box diagrams illustrating various views ofembodiments of the present invention for an intraluminal supportstructure; FIG. 1A showing a planar crimped configuration; FIG. 1Bshowing a planar un-crimped configuration; FIG. 1C showing a long axisfolded configuration; FIG. 1D showing a short axis folded configuration;

FIG. 1E-1G show schematic illustration of a close up views of optionalbasic unit structures 10 utilized to form the support structure 50according to embodiments of the present invention;

FIG. 2A-2E show various views of an illustrative schematic diagram ofthe prosthetic valve assembly in its final post-delivery configurationonce placed at the implantation site according to embodiments of thepresent invention;

FIG. 3A-3E show various views of an illustrative schematic diagram ofthe prosthetic valve in the open non-crimped planar configurationaccording to embodiments of the present invention;

FIG. 4 show a perspective view of an illustrative schematic diagram ofthe prosthetic valve support structure in the open crimped configurationaccording to embodiments of the present invention;

FIG. 5A-5B show various view of an illustrative schematic diagram of asupport structure in the folded final configuration according toembodiment of the present invention.

FIG. 6A-6D show various views of an illustrative schematic diagram of aprosthetic valve assembly according to embodiments of the presentinvention; FIG. 6A shows an open crimped configuration; FIG. 6B shows anon-crimped planar configuration; FIG. 6C shows a partially foldedconfiguration; FIG. 6D shows a close up schematic view of optionallocking members utilized to closed the folded configuration of thesupport structure of the present invention.

FIG. 7 shows a schematic illustration of a delivery system for thesupport structure according to embodiments of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is for a vessel support structure, such as a stentor valve that is delivered to an implantation site in a crimped planarconfiguration so as to provide greater flexibility when maneuvering thesupport structure through the anatomy while leaving a small scarringsignature.

The vessel support structure according to the present invention may befurther configured to provide a valve support structure forming aprosthetic valve.

The vessel support structure of the present invention is configured tobe introduced into the body in a crimped planar configuration duringdelivery and until it reaches its implantation site. Once at theimplantation site the support structure is deployed from a deliverysheath wherein the support structure gradually expands to assume itsfinal folded configuration. During deployment the open crimped supportstructure is configured to transition from its small open crimpeddelivery configuration to assume its final folded shape so as to assumea vessel support structure configuration that may be utilized as vesselsupport for example in the form of a stent or a prosthetic valve.

In embodiments the final shape of the vessel support structure may beconfigured to assume any structural geometric shape, folded shape, openfolded shape, closed folded shape for example including but not limitedto cylindrical, bifurcated, furcated, trapezoidal cylinder, curvilinear,tertiary structure, secondary structure helical, double helix, looped,lobular, ellipsoid, ovoid, paraboloid, vortex, hyperboloid, hyperbola,parabola, conical section, toroidal, sigmoidal, multi-loop, solenoidal,any combination thereof or the like.

The open crimped configuration utilized during delivery provides bothflexibility and maneuverability while assuming a small dimension. Inparticular the open crimped configuration allows a practitioner tomaneuver within complicated anatomy and more readily allows the deviceto assume acute angles, not readily possible with state of the artdevices.

In some embodiments the open crimped vessel support structure may befurther fit with at least a portion of a valve anatomy, for example atleast two or more valve leaflets, so as to allow formation of aprosthetic valve having at least two or more leaflets in the foldedfinal configuration. Preferably portions of the valve anatomy fit ontothe vessel support structure are similarly capable of assuming a smallprofile and/or crimped configuration allowing the open crimped vesselsupport structure to retain its flexibility and maneuverability.

In embodiments the prosthetic valve may for example be configured toform a prosthetic valve of the human or animal body in any anatomicalstructure, organ, or form of a valve; for example including but notlimited to semilunar valve, pulmonary valve, aortic valve,atrioventricular valve (AV valve), mitral valve, bicuspid valve,tricuspid valve, sphincter, cervix, or the like.

In embodiments the final structural configuration of the anatomicalsupport structure may be composed of a plurality of support structuresthat may be interlinked, intertwined, coupled and/or associated with oneanother during the implantation and/or deployment process so as to forma final structural configuration of the support structure. For example,two or more support structures may be delivered to an implantation sitesubstantially simultaneously and/or sequentially in order to allow themto be coupled and/or functionally associated with one another, so as toform a complex support structure during deployment, for example, abifurcated support structure and/or a helical and/or double helixconfiguration, or the like.

The principles and operation of the present invention may be betterunderstood with reference to the drawings and the accompanyingdescription. The following figure reference characters are usedthroughout the description to refer to similarly functioning componentsare used throughout the specification hereinbelow.

-   -   10 basic structure;    -   10 a angel;    -   10 o open structure;    -   10 f filament;    -   10 s sigmoidal connecting structure;    -   50 support structure;    -   50L long axis;    -   50 s short axis;    -   50 c open crimped configuration;    -   50 e open non-crimped planar configuration;    -   50 f closed non-planar folded configuration;    -   52 support structure body;    -   54 locking members;    -   54 c closed/interlocked members;    -   55 axial support member;    -   100 prosthetic valve assembly;    -   100 c open crimped configuration;    -   100 e open non-crimped planar configuration;    -   100 f closed non-planar folded configuration;    -   100 o valve outflow end;    -   100 i valve inflow end;    -   102 valve support structure body;    -   102 c support structure crimped configuration;    -   104 coupling locking member;    -   110 valve body;    -   112, 114, 116 valve leaf;    -   118 valve annulus;    -   150 prosthetic atrio-ventricular valve;    -   150 c crimped planar configuration;    -   150 e extended planar configuration;    -   150 f folded configuration;    -   152 support structure body;    -   152 a upper support structure portion;    -   152 b medial support structure portion;    -   152 c lower support structure portion;    -   152 s sigmoidal connecting member;    -   154 coupling members;    -   154 a first coupling member;    -   154 b second coupling member;    -   155 axial support member;

FIG. 1A-D shows the different configurations assumed by the intraluminalsupport structure 50 according to embodiments of the present invention.Namely, support structure is capable of assuming an open crimpedconfiguration 50 c as shown in FIG. 1A, an open non-crimped planarconfiguration 50 e as shown in FIG. 1B, and optional foldedconfigurations 50 f in the form of a stent-like tubular structure 200shown in FIG. 1D, and in the form of a valve-like cylindrical structure100 shown in FIG. 1C.

FIG. 1A shows schematic illustrative diagram of the open crimpedconfiguration 50 c of support structure 50. The open crimpedconfiguration 50 c is configured to have a short axis 50 s and a longaxis 50L. Importantly support structure 50 c is flat and/or planar so asto assume minimal dimensions along short axis 50 s. Such minimizationalong the short axis 50 s provides the support structure withmaneuverability so as to improve its delivery to an anatomical deliverysite where it transitions to its final folded configuration 50 f, FIG.1C-D.

The transition from the open non-crimped planar configuration 50 e,shown in FIG. 1B, involves crimping across long axis 50L of supportstructure 50, as shown by the directional arrows.

Accordingly the crimped planar configuration 50 c is advantageous inthat it allows for improved maneuverability of the support structure 50c within the anatomy during the support structure's delivery. Aspreviously described this open crimped configuration 50 c according tothe present invention allows a practitioner to conveniently maneuver thesupport structure during delivery while further allowing thepractitioner to readily urge the device to assume sharp and/or acuteangels, particularly through tortuous anatomy. Furthermore, the opencrimped configuration 50 c provides a profile further enables apractitioner to reduce scarring size and/or signature when penetratingthrough tissue for example cardiac tissue such as the cardiac septum.Crimping support structure 50 e provides an elongated open crimpedconfiguration, however one that remains sufficiently flexible so as tobe able to assume acute angles while being delivered within the anatomy.The longitudinal crimping reduces the width of support structure 50 ealong short axis 50 s by about at least 20% and more preferable up toabout 80%, while increasing the length 102L by a factor of up to about100%. Therefore the delivery configuration has a small short axis 50 sthat is advantageous in that it is readily maneuverable.

Support structure 50 may take optional forms for example including butnot limited to a vessel support structure to maintain vessel patencysuch as a stent, FIG. 1C, or may be utilized as an orifice forsupporting a valve body, FIG. 1D.

Support structures 50 may be provided from optional biocompatiblematerials for example including but not limited to polymers, alloys,smart materials, shape memory materials, nitinol, materials exhibitingplastic deformation, super-elastic metal alloy which transforms from aaustenitic state to a martensitic state, any combination thereof or thelike as is known in the art.

In some embodiments at least a portion of support structure 50 may becoated with an agent and/or medicament and/or drug to form a drugeluting support structure, for example as is known in the form of a drugeluting stent.

Support structure 50 is configured to remain in the open crimpedconfiguration 50 c during both the introduction (into the anatomy) untilreaching the implantation and/or placement site. During deployment atthe implantation site, support structure 50 c is configured totransition and/or transform into its folded configuration 50 f forexample assuming a stent-like shape, FIG. 1C, or valve-like shape, FIG.1D, at the implantation site. Accordingly, as the open crimped supportstructure 50 c is delivered into the implantation anatomy it begins toexpand so as to assume its final folded configuration 50 f.

In embodiments the folded configuration 50 f may be configured to assumea variety of optional configuration for example including but notlimited to any structural geometric shape, curvilinear shape, foldedshape, open folded shape, closed folded shape, cylindrical, bifurcated,furcated, trapezoidal cylinder, curvilinear, tertiary structure,secondary structure helical, double helix, looped, lobular, ellipsoid,ovoid, paraboloid, vortex, hyperboloid, hyperbola, parabola, conicalsection, toroidal, sigmoidal, multi-loop, solenoidal, any combinationthereof or the like.

During transformation and/or transitioning support structure 50 c, mayundergo a progressive unfolding and/or unraveling and folding processincluding expansion, rotation, and torsion, along short axis 50 s and/orlong axis 50L so as to assume its final shape 50 f within the anatomicalimplantation site.

Support structure 50 may be expanded from its crimped configurationalong its long axis 50L in a rotated or torsade manner around a centralaxis in order to obtain its work configuration with a curvilinear or thelike folded and/or circular structure.

In some embodiments a plurality of crimped support structures 50 c maybe transformed substantially simultaneously so as to combine to form afinal complex structural configuration, for example including but notlimited to a bifurcated support structure or the like, not shown.

The transformation form a planar crimped support structure 50 c to thefolded configuration 50 f of support structure 50 is provided at theanatomical delivery site. The transformation may be provided bycontrolling the transformation conditions at the delivery site. Forexample, the transformation may be triggered and/or initiated inresponse to exposure to a triggering agent and/or signal for exampleincluding but not limited to a temperature change, either an increaseand/or a decrease. A transformation triggering agents and/or signal mayfor example include but is not limited to at least one or more, or acombination of selected from: temperature change, chemical agent,electromagnetic field, electromagnetic current, acoustic signal, opticalsignal, magnetic field, the like as is known in the art or anycombination thereof.

Preferably following and/or during the final stages of thetransformation phase the planar crimped structure is closed andinterlocked and/or folded and/or overlapping onto itself to define aclosed structure 50 f along at least one of a short side 50 s, a longside 50L, or a combination thereof.

In embodiments support structure 50 may comprise at least one or morecoupling and/or locking members 54 that provided for folding and/orclosing the support structure to its closed folded configuration 50 f Inembodiments locking members 54 may be located along any portion ofsupport structure 50 for example including but not limited to short axis50 s, long axis 50L, support structure body 52, or any combinationthereof.

In some embodiments support structure 50 may comprise two or morecoupling and/or locking members 54 that are provided in optional formsand configured to correspond and/or lock with one another. Optionallythe two or more coupling member may correspond to one another.

In embodiments locking members 54 may be coupled with one another withthe aid of a dedicated tool, for provided in optional forms for exampleincluding but not limited to plyers, leads, guidewire, leading wires,threading wire, the like or any combination thereof.

In embodiments corresponding locking member 54 may be coupled to form aninterlocked and/or closed coupling member 54 c, for example as shown inFIG. 1C-D.

In embodiments locking members may be provided in optional forms forexample including but not limited to pin and hooks, male/femalecouplers, peg and recess, latch and buckle, sutures, hook and loop, wirethe like or any combination thereof.

In embodiments couplers 54 may optionally be provided in the form of abiocompatible adhesives and/or cement that may be cured duringdeployment process.

In some embodiments support structure 50 may be provided in the form ofa substantially rectangular configuration having opposing long edgesalong long axis 50L and opposing short edge along short axis 50 s, thatdefine a support structure body 52. The support structure body 52 isformed from a plurality filaments 10, shown in FIG. 1E-G. Supportstructure is not limited to a rectangular configuration as shown here itmay assume any shape.

Support structure body 52 is provided from a plurality of basicstructures 10, FIG. 1E-G, that form of a braided scaffold structure offilaments 10 f defining a plurality of interlinking points 10 i thatform a rhomboid recess 10 o. The interlinked filaments forming recess 10o along an intersection point 10 i provides the necessary flexibility ofsupport structure 50 and the capability of assuming the variousconfiguration of support structure including open crimped configuration50 c, folded 50 f, and open non-crimped planar 50 e, as shown in FIG.1A-D.

In embodiments, the basic structure 10 provides support member 50 withthe ability to control and assume the different configurations bycrimping along at least one dimension of the support structure body 52,either along its long side 52L or short side 52 s. Accordinglycontrolling the relative position of filaments 10 relative to oneanother allows body 52 to assume the smaller open crimped configuration50 c prior to introduction into a delivery sheath and/or device, forexample a catheter (not shown); or to assume the larger configuration inthe form of an open non-crimped planar configuration 50 e, and finally afolded configuration 100 f during deployment at the implantation sitefollowing a transition phase.

FIG. 1E-G show the basic units 10 that may be utilized to form a supportstructure 50 is formed from a plurality of filaments 10 f, arranged atan angle 10 a relative to one another forming an intersection 10 idefining an opening 10 o.

In some embodiments, opening 10 o may assume a polygonal shape, FIG. 1E,resembling at least one or more of a parallelogram, a rhombus, a regularrhomboid, an irregular rhomboid, or the like polygon or quadrilateral.In some embodiments opening 10 o may assume a closed curvilinearconfiguration, FIG. 1F, resembling a circle, ovoid, ellipsoid, circularlike structure, or the like closed curvilinear structure.

More preferably support structure is configured such that the angle 10 aformed at filament intersection 10 i is controllable to determine thedimensions of the support structure 50.

In some embodiments, as shown in FIG. 1G, filament intersection 10 i maybe provided in the form of a sigmoidal connecting structure 10 s, asshown. Such a sigmoidal connecting structure 10 s renders additionalflexibility along the long axis 50L therein allowing the intersection tobe stretched and condensed in the long axis 50L controlling the shapeand size of structure 50.

Support structure flexibility is obtained from its structure comprisinga plurality of angled intersections wherein the intersection angle 10 a,is controllable in that it may be changed when transitioning between thecrimped planar 50 c and the open non-crimped planar 50 e configurationsor vice versa.

In embodiments the polygonal recess 10 o may be distributed in anymanner along support structure 50 to form a desired configuration ofsupport structure 50.

In embodiments support structure 50 may be provided from a sheetmaterial that is laser cut to assume the support structureconfiguration, defining a plurality of polygonal recess 10.

In embodiments support structure 50 may be provided by way of braidingand/or weaving of a plurality of filaments 10 f to form the supportstructure. During the braiding of a plurality of filaments the anglesformed between filaments may be controlled so as to form the desiredpolygonal intersecting structure.

In embodiments the size of basic structure 10 is controllable so as toallow it to assume a planar crimped configuration 50 c having minimalshort dimension (FIG. 1A), or open non-crimped planar configuration 50 ehaving maximal short dimension (FIG. 1B).

In embodiments, the support structure 50 comprising a plurality ofpolygon frame structures 10 is expandable in its long axis in a linear,rotated or torsade manner around a central axis in order to obtain itswork configuration with a circular shape.

In some embodiments support structure body 52 may optionally furtherfeature at least one or more axial support member 55, an example ofwhich is shown in FIG. 1A. Axial support member 55 provides alongitudinal axis and/or anchor point along the long dimension 50L ofbody 52. Axial support member 55 may be provided in the form of acontinuous flexible sheet utilized to increase the strength of foldedconfiguration 50 f by providing an anchoring axis while retaining theflexibility of the planar-crimped configuration 50 c. Axial supportmember 55 may feature a locking member 54 at an end thereof, asdescribed in greater detail with respect to FIG. 6A-D.

FIG. 2A shows a perspective side view of an intraluminal supportstructure in the form of a prosthetic valve 100 according to embodimentsof the present invention. FIG. 2A shows the prosthetic valve 100 in itsfinal deployed configuration as it would be deployed within the requiredanatomy, for example including but not limited to the heart so as toreplace a cardiac valve.

Prosthetic valve 100 includes a cylindrical support structure 102 thatis fit with a valve body 110.

In embodiments valve body 110 may comprise at least two or more leaflets112, 114,116. Valve body 110 is a provided from prosthetic valve tissueor tissue like membrane that may be made of variable biocompatiblematerials for example including but not limited to biological tissue,biological matter, engineered materials, grown materials, transplantedtissue, biocompatible polymeric materials, the like materials or anycombination thereof.

In embodiments valve body 110 may be configured in terms of sizing,shape, number of leaflets, according to at least one valve parameter forexample including but not limited to the intended anatomy, theimplantation site, form and function of the prosthetic valve, or anycombination thereof.

Support structure 102 forms a cylindrical body having a radius andheight that are configured according to the intended form and functionof the prosthetic valve 100. Sizing of the support structure isaccordingly adjusted and/or configured according to the intendedanatomy, implantation site, form and function of the prosthetic valve,or any combination thereof.

FIG. 2A-E show support structure 100 in its final deployed and foldedform 100 f. Accordingly, in its final folded form 100 f supportstructure 102 defines a cylindrical body formed from a support structurethat has folded over itself over a short edge and coupled alongcorresponding short ends. As shown, the short edge of support structure102 overlap over corresponding locking members 104 so as to form thefolded cylindrical structure 100 f.

Locking members 104 are utilized to form the cylindrical shape ofprosthetic valve body 100. Folding of support structure provides forforming overlapping portions of the support structure 102, for examplealong its short axis 102 s or long axis 102L, shown in FIG. 3A. Suchoverlapping may be configured to allow for locking and/or closing thesupport structure with locking members 104 enabling support structure toassume its final folded shape configuration 100 f.

The support structures 102 in its working folded configuration definesan inflow end 100 i, shown in FIG. 2B-C, and an outflow end 100 o, shownin FIG. 2D-E.

Most preferably during deployment with the necessary tools the supportstructure 102 expands from the open crimped configuration 100 c,utilized during introduction and delivery as shown in FIG. 4, to assumethe folded circular shape 100 f, as shown in FIG. 2A-E.

Once folded placed and functionally integrated within the appropriateanatomical structure, valve 100 is rendered functional wherein valvebody 110 to ensures a one-way fluid direction from the inflow end 100 i,FIG. 2B-C, to the outflow end 100 o, FIG. 2D-E.

FIG. 2B shows a top down view of the proximal surface of the prostheticvalve 100 revealing the commissural juncture of valve body 110,exemplarily shown in the form of a three leaflet valve utilizingleaflets 112,114,116, therein defining the inflow end 100 i, forming aprosthetic tricuspid valve.

FIG. 2C shows a perspective top down view of the prosthetic valveassembly 100 depicted in FIG. 2B, therein showing the inflow end 100 i.

FIG. 2D shows a perspective bottom up view of the distal surface of theprosthetic valve 100, revealing the outflow end 100 o.

FIG. 2E shows a perspective side view of valve assembly 100, furthershowing the valve body formation.

FIG. 3A-E show various views of prosthetic valve 100 in the opennon-crimped planar configuration 100 e showing an expandedconfiguration. The expanded/non-crimped configuration 100 e depicts thepre-crimped configuration of valve 100, prior to crimping in preparationfor introduction and delivery within the anatomy. Most preferablycrimping of open non-crimped planar configuration 100 e is provided withdedicated process and tools so as to allow placement of valve 100 into adelivery system 250 for example utilizing a catheter and/or sheath 220,as schematically shown in FIG. 7.

In some embodiments the fully open non-crimped planar configuration 100e may be used during deployment within the anatomical implantation site.More preferably, during deployment of valve 100 is configured totransition from the open crimped configuration 100 c to the foldedconfiguration 100 f wherein the open non-crimped planar configuration100 e is a temporary and/or gradual transitional phase for portion ofthe valve body 102 such that the fully open non-crimped planarconfiguration 100 e, as shown, is not necessarily realized within theimplantation site.

In embodiments the open non-crimped planar configuration 100 e may beassume the folded configuration 100 f by optional means and/or tools forexample including but not limited to folding, rotation, torsion, and/oroverlapping along a short axis 102 s. The open non-crimped planarconfiguration 100 e as shown in FIG. 3A-E are shown here forillustrative purposes only as preferably it is not a state that ismaintained for an extended period of time within the anatomy. Preferablywithin the implantation site anatomy the transformation and/ortransition from a crimped planar configuration 100 c, FIG. 4, to thefolded final configuration, 100 f as shown in FIG. 2A, takes place in anefficient manner such that the transition phase, for example includingbut not limited to folding, torsion occurs, simultaneously during thetransformation process, such that the fully open non-crimped planarconfiguration of the vessel support structure is in its largest expandeddimensions is generally not exhibited within the anatomy.

In some embodiments the vessel support structure may be delivered and/orplaced within the implantation site in an open non-crimped planarconfiguration 100 e.

FIG. 3A shows the internal surface of valve assembly 100 that is fitwith a valve body 110 showing individual valve leaflets 112, 114, 116 ofand valve annulus 118 that form valve body 110 that is featured alongthe open non-crimped planar surface 100 e of support structure 102.

In embodiments, valve body 110 is associated with and/or coupled withsupport structure 102 to form prosthetic valve 100, in a manner as isknown and accepted in the art for example including but not limited tosuturing, biocompatible adhesives, mounting clips, couplers, anycombination thereof or the like as is known in the art.

FIG. 3B shows an external surface view of valve assembly 100 that showsthe support structure 102 and coupling members 104. Coupling members 104are utilized to form the folded structure valve assembly 100 f so as toprovide a cylindrical conformation 100 f from the planar conformation100 e, 100 c by way of folding over short edges and utilizing couplingmembers 104 to lock short edges. Coupling members 104 are shown in anoptional configuration herein depicted in the non-limiting form of pegsthat may be manipulated to interlock the short ends 102 s of supportstructure 102.

Embodiments of the present invention are not limited to this form ofcoupling and/or locking members and may be provided in any form forexample including but not limited to male/female couplers, peg andrecess, latch and buckle, sutures, hook and loop, wires, correspondingthreading, the like or any combination thereof.

In embodiments locking members 104 may be locked with the aid of adedicated tool, provided in optional forms, for example including butnot limited to plyers, leads, guidewire, leading wires, threading wire,the like or any combination thereof.

In embodiments coupling member 104 may be provided from dedicated smartmaterials, shape memory materials that are configured to undergo aspecific transition to assume the locked configuration when exposed totransitioning conditions and or elements during the deployment process.

In embodiments couplers 104 may optionally be provided in the form of abiocompatible adhesives and/or cement that may be cured duringdeployment process.

Optionally coupling members 104 may be provided in the form of pin andhooks so as to allow for the overlapping extremity to form anoverlapping tight and stable seal between overlapping edges, for exampleas shown in FIG. 2A.

Optionally support structure 100 may comprise two or more couplingand/or locking members 104 that are provided in optional forms andconfigured to correspond and/or lock with one another.

FIG. 3A shows a face on view from the short end 102 s showing a leaflet112,114,116 and annulus 118 of valve body 110 as extending away fromsupport structure 102. FIG. 3C shows an end view of valve 100 showingthe placement of valve body 110 relative to support structure 102.

FIG. 3D shows a face on view of external surface of valve assembly 100similar to the depicted in FIG. 3B.

FIG. 3E shows a perspective view along the long edge 102L of supportstructure 102

FIG. 4 shows schematic diagram of the crimped-planar configuration 100 cof support structure 100 where for illustrative purposes valve body 110is removed. As shown, support structure 102 in its open crimpedconfiguration 100 c is provided in the form of a support structurehaving a minimal dimension along the short end of axis 102 s. Thetransition from the open non-crimped planar configuration 100 e, shownin FIG. 3B, involves crimping across opposing long edges of long axis102L of support structure 102, as shown by the directional arrows. Suchcrimping provides a long configuration however one that remainssufficiently flexible so as to be able to assume an acute angle whilebeing introduced within the anatomy. The longitudinal crimping reducesthe width of support structure 102 along short edge of short axis 102 sby about at least 20% and more preferable up to about 80%, whileincreasing the length of axis 102L by a factor of up to about 100%.Therefore the delivery configuration has a small short edge along axis102 s that is advantageous in that it is readily maneuverable intortuous anatomy and has a small scar size and/or signature whenpenetrating through cardiac tissue for example including but not limitedto cardiac septum.

FIG. 5A-B show various view support structure 102 that is foldedassuming its final configuration in the form of a stent. Structure 102is shown where is folded over the short edge of axis 102 s, however itmay similarly be folded along its long edge of axis 102L.

FIG. 5B shows two short edges of axis 102 s that are interlocked overlocking members 104. The location of locking members may be controlledin order to determine the final structural shape of support structure102.

FIG. 6A-D shows an optional embodiment for a prosthetic valve supportstructure 150 featuring an axial support member 155. Axial supportmember preferably provides additional structural integrity and strengthalong the length of valve 150 while maintaining both maneuverability andflexibility of the overall structure 150. In embodiments axial supportmember 155 may be provided from a valve support structure 150 includestwo axial support members 155 are disposed along the long axis 150L.FIG. 6A shows an open crimped configuration 150 c. FIG. 6B shows an opennon-crimped planar configuration 150 e. FIG. 6C shows an openconfiguration of a partially folded configuration 150 f of valve 150

The two axial support members define three sub segments of supportstructure body 152 including an upper portion 152 a, a medial portion152 b and a lower portion 152 c.

In embodiments upper portion 152 a may be formed from a plurality ofbasic structures 10 extending above a first axial support member 155 a.In an optional embodiment each basic structure 10 of upper portion 152 amay be individually connected to and extending from the first axialsupport member 155 a. In an optional embodiment a plurality of basicstructure 10 may be interconnected with one another and collectivelyextend from first axial support member 155 a, so as to form upperportion 152 a. In embodiments interconnected basic structures 10 may becoupled and/or associated with one another utilizing a sigmoidalconnecting member 152 s.

In embodiments lower portion 152 c may be formed from a plurality ofbasic structures 10 extending below a second axial support member 155 b.In an optional embodiment each basic structure 10 of lower portion 152 cmay be individually connected to and extend from second axial supportmember 155 b. In an optional embodiment a plurality of basic structure10 may be interconnected with one another and collectively extend fromsecond axial support member 155 b, so as to form lower portion 152 c. Inembodiments interconnected basic structures 10 may be coupled and/orassociated with one another utilizing a sigmoidal connecting member 152s, for example as shown.

In embodiments medial portion 152 b may be formed from a plurality ofinterconnected basic structures 10 disposed between a first axialsupport member 155 a and a second axial support member 155 b, thereinconnecting both axial support members 155. In embodiments interconnectedbasic structures 10 may be coupled and/or associated with one anotherutilizing a sigmoidal connecting member 152 s, for example as shown.

In embodiments each support structure portion 152 a,b,c may beindividually crimped to assume an open crimped configuration.

In embodiments each support structure portion 152 a,b,c may beindividually un-crimped to assume an open non-crimped planar and/orfolded configurations.

In embodiments medial portion 152 b is preferably crimped to assume acrimped planar configuration as previously described, for example asshown in FIG. 6A. The open crimped configuration may be achieved bycrimping along short axis so as to urge axial support members 155 towardone another, as is depicted by the directional arrow. FIG. 6B shows theopen non-crimped planar configuration 150 e where medial portion 152 bis extended as shown with directional arrow wherein support members 155a,b are extended away from one another.

FIG. 6C shows as folded configuration 150 f of prosthetic valve supportstructure 150 in an open configuration, as it would appear followingdeployment in the implantation site anatomy and prior to closure of theprosthetic valve utilizing corresponding locking members 154, so as toform the closed valve structure (no shown).

In embodiments support member 155 may optionally and preferably featurea locking member 154 along an end thereof, for example as shown. FIG.6A-D shows a close up view of optional locking members 154 provided inthe form of a male latch member 154 a and female buckle member 154 bconfiguration. As previously described locking members may be providedin a plurality of optional forms.

In some embodiments locking members 154 may be coupled with one anotherwith the aid of a dedicated tool, provided in optional forms for exampleincluding but not limited to plyers, leads, guidewire, leading wires,threading wire, the like or any combination thereof.

FIG. 7 shows a schematic illustration of the process of delivering anddeploying the support structure 50, 100, 150 as previously described,that is delivered with a delivery sheath and/or catheter 220 once loadedforming a delivery catheter 250. An additional advantage of the supportstructure according to the present invention is that a single deliverysystem, for example a catheter and/or sheath 250 may be utilized for aplurality of optional support structures having variable diametersand/or sizes. That is because the final shape of the foldedconfiguration 50 f has no bearing on the delivery system. This is animprovement over the state of the art delivery systems that must bespecific relative to the size of the support structure being delivered.

Accordingly embodiment of the present invention provide for use of asingle delivery system irrespective of the final diameter and/or size ofthe support structure being delivered this is specifically due to thecrimping along the short axis as previously described.

While the invention has been described with respect to a limited numberof embodiment, it is to be realized that the optimum dimensionalrelationships for the parts of the invention, to include variations insize, materials, shape, form, function and manner of operation, assemblyand use, are deemed readily apparent and obvious to one skilled in theart, and all equivalent relationships to those illustrated in thedrawings and described in the specification are intended to beencompassed by the present invention.

Therefore, the foregoing is considered as illustrative only of theprinciples of the invention. Further, since numerous modifications andchanges will readily occur to those skilled in the art, it is notdescribed to limit the invention to the exact construction and operationshown and described and accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

It should be noted that where reference numerals appear in the claims,such numerals are included solely or the purpose of improving theintelligibility of the claims and are no way limiting on the scope ofthe claims.

Having described a specific preferred embodiment of the invention withreference to the accompanying drawings, it will be appreciated that thepresent invention is not limited to that precise embodiment and thatvarious changes and modifications can be effected therein by one ofordinary skill in the art without departing from the scope or spirit ofthe invention defined by the appended claims.

Further modifications of the invention will also occur to personsskilled in the art and all such are deemed to fall within the spirit andscope of the invention as defined by the appended claims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable sub-combination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the scope of the appendedclaims.

Citation or identification of any reference in this application shallnot be construed as an admission that such reference is available asprior art to the invention.

Section headings are used herein to ease understanding of thespecification and should not be construed as necessarily limiting.

While the invention has been described with respect to a limited numberof embodiments, it will be appreciated that many variations,modifications and other applications of the invention may be made.

What is claimed is:
 1. A method for delivering an intraluminal supportstructure to an implantation site in a human or animal body, wherein theintraluminal support structure has a planar configuration with a longaxis and a short axis, said method comprising: advancing a distal end ofa delivery catheter through a body lumen to the implantation site,wherein the intraluminal support structure is carried on the distal endof the delivery catheter in a d configuration which is elongated alongthe long axis and has a reduced width along the short axis;transitioning the intraluminal support structure from its crimpedconfiguration to a non-crimped configuration at the implantation site;folding the non-crimped intraluminal support structure to assume anon-planar folded configuration at the implantation site; and lockingthe non-crimped intraluminal support structure in the foldedconfiguration; wherein the intraluminal support structure is implantedit its locked, folded, non-crimped configuration.
 2. The method of claim1, wherein the implantation site comprises a cardiac valve annulus. 3.The method of claim 2, wherein the intraluminal support structurecomprises a prosthetic valve assembly coupled to a support structurebody.
 4. The method of claim 3, wherein folding the non-crimpedintraluminal support structure to assume a non-planar foldedconfiguration at the implantation site comprises forming the supportstructure body into a cylindrical structure.
 5. The method of claim 4,further comprising locking ends of the support structure body togetherto maintain the cylindrical structure.
 6. The method of claim 5, whereinindividual leaflets of the prosthetic valve assembly are fit togetherwhen the support structure body is formed into a cylindrical structure.7. The method of claim 1, wherein the intraluminal support structure iscarried in its crimped configuration inside the distal end of thedelivery catheter.
 8. The method of claim 1, wherein locking thenon-crimped intraluminal support structure in the folded configurationcomprises overlapping and interlocking ends of said intraluminal supportstructure along the short axis.
 9. The method of claim 1, wherein saidlocking members interlocking ends of said intraluminal support structurealong the short axis comprises joining any one or combination of pins,hooks, male-female couplers, peg-recess couplers, latches, buckles,sutures, wires, threads, hooks, and loops.
 10. The method of claim 1,wherein the intraluminal support structure body comprises a planarscaffold formed as an arrangement of filaments having interlinkingpoints
 11. The method of claim 10, wherein the filaments are arranged byone of braiding, weaving, interlacing, or any combination thereof. 12.The method of claim 1, wherein the non-crimped intraluminal supportstructure is locked, and folded at a final implanted location.
 13. Themethod of claim 1, wherein further comprising maneuvering the locked,folded, non-crimped intraluminal support structure to a final implantedlocation.